MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-88-60
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 mast roller pump gave a motor controller failure error message during priming.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 mast roller pump.The incident occurred in kuwait.A livanova field service representative was dispatched to the facility to investigate the device: motor power amplifier circuit board (hmf) and motor controller circuit board (hms) have been checked and no deviation was found.The reported problem has been reproduced and thus the pump is defective and the unit will be sent to livanova deutschland for further inspection and repair.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: the affected part was returned to livanova deutschland for a detailed investigation.The technician could confirm the reported issue.In order to solve it, complete pump head was replaced and as preventive maintenance also the pump cover was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A device service history review has been performed and identified that the unit was manufactured in 2023 and no other similar event has been reported for this unit.Taking into account all the collected information and repair activity, the most likely root cause has been assigned to a loosened fixation of resolver inside the pump head.

• Brand Name: S5 MAST ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19403891
• Report Number: 9611109-2024-00233
• Device Sequence Number: 12499315
• Product Code: DTQ
• UDI-Device Identifier: 04033817900481
• UDI-Public: (01)04033817900481(11)230214
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K062396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10-88-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown